- Envista Holdings Corporation (Quakertown, PA)
- …Engineering, Operations, and Purchasing/Procurement to ensure product quality and compliance requirements are met with on-going production demands. The position ... products comply with the US Food and Drug Administration ( FDA ), local and state agencies and global health authority...+ Execute process improvements as they relate to QMS compliance with ISO/GMP requirements + Identify and drive Corrective… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory...Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory...Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the… more
- American Red Cross (Philadelphia, PA)
- …Spring Garden St. facility in Philadelphia, PA. The facility is regulated by the FDA . It is 245,000 square feet. **Experience working in an FDA -regulated, GPM ... problematic mechanical devices. Perform all duties and responsibilities in compliance with standard operating procedures and other applicable Federal, State,… more
- Globus Medical, Inc. (Audubon, PA)
- …design specifications for new product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project + Manage of all ... ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory...Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + Collaborate with the… more
- Teleflex (Wyomissing, PA)
- …projects and design changes in production. * Ensure projects are developed and documented in compliance with the Quality System and with FDA and ISO standards. * ... basic statistical analyses using Minitab or equivalent software. Regulatory and Compliance : * Familiarity with design control processes, regulatory requirements (eg,… more
- Sanofi Group (Swiftwater, PA)
- …technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core ... Inspections. + Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China),… more
- Legrand NA (Canonsburg, PA)
- …in document control practices, drive continuous improvement initiatives, and support regulatory compliance efforts. This newly created position is due to growth and ... including procedures, manuals, records, and technical reports. + Regulatory Compliance Leadership:Ensure all document control practices comply with industry… more
- Merck (Harrisburg, PA)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- TreeHouse Foods, Inc. (Lancaster, PA)
- …pretzels. This role upholds product quality, food safety, and sanitation in compliance with company standards and regulatory requirements. **_You'll add value to ... Define and enforce best laboratory practices and quality policies. . Ensure compliance with company, state, and federal sanitation regulations. . Collaborate with… more